VANCOUVER, BC, Nov. 30, 2020 /CNW/ - Sirona Biochem
Corp. (TSX-V: SBM) (FSE: ZSB) (US-OTC: SRBCF) ("Sirona") is
pleased to provide an update from the Company's CEO, Dr.
Howard Verrico.
Dear Shareholders,
This year, we decided to provide our investor community with a
FAQ format as an update on some of the progress and activities
currently underway at Sirona.
Q: Will we have any news before the end of 2020?
Sirona's projected milestones will occur within the next 7
months. As per our Investor PowerPoint, we have provided a list of
items we feel are within our control and our goal remains to
announce them within that timeframe. Estimating timelines is
difficult for two reasons. One is that many of our milestones rely
on partner organizations and we cannot control their progress or
what they choose to make public, and two, research and development
can often take unexpected pathways. There are times when we need to
switch strategies based on results and/or resources available, but
our decisions are always in the best interest of increasing
shareholder value. While we do our best to estimate project
outcomes and timelines, they are based on variable factors and can
change without notice.
Q: In your interview with Smallcap-Investor, you said there
would be news in early 2020 from Wanbang. Is this still
expected?
The Wanbang trial was delayed due to COVID-19 early in the
pandemic. The delay was relatively brief as the infections were
quickly brought under control, but it did have an impact on the
timing of the studies. Wanbang have restarted and we have been
informed that the trial is currently meeting expectations of
efficacy and safety. Wanbang is in full control of publicly
released information on their trials and advancement of the SGLT2
inhibitor. When they choose to announce, we will immediately inform
our investors. If they reach a milestone which triggers a payment
to Sirona, then Sirona can issue an independent release as required
by stock exchange rules. Consultation with Wanbang would always be
part of the process as we maintain our excellent working
relationship.
Q: What is happening with the Huaxi deal?
We have been actively performing due diligence on Huaxi with the
assistance of Sirona's consultants on the ground in China. We have found that Huaxi has
experienced internal delays so, in parallel, we have decided to
talk to other potential partners in China. Over the past month, we have executed
several confidentiality agreements and begun introductory meetings
as well as due diligence. Huaxi may still proceed or the company
may become a participant in a larger group. The interest in Sirona
and TFC-1067 remains high. We must spend the time and effort to
secure the right partner. China is
too important to make a strategic misstep with a partner in an
effort to rush the product to market. We will secure the right
group or groups to move this forward.
Q: What is happening with the Tinyi deal? Will they still be
our distribution partner in China?
Tinyi is still expecting to be a distribution partner for
TFC-1067 in China. They are also
potentially looking to be part of a larger transaction. As in the
above response, Sirona is ideally looking for an integrated team
based in China to manage all
aspects of commercialization. We are actively moving toward this
plan with the due diligence of several competent partner groups.
This will maximize our growth potential and free up resources to
expand into other countries. This aligns with Sirona's business
model to partner and licence our technology with leading industry
companies that have established abilities in all aspects of
commercialization including manufacturing, regulatory, distribution
and sales in local markets around the world. Sirona will grow by
doing what it does best, innovation of new cosmetic and therapeutic
agents using its proven platform technology.
Q: How long will it take to get CFDA approval for
TFC-1067?
We anticipate updates on this issue as regulations are
undergoing a major reform. This is something we are planning for
our partner to manage but are also actively talking to leading
experts on the regulatory landscape.
Q: Why is the Rodan + Fields launch taking so long?
Rodan + Fields spend a great deal of time preparing the
introduction of their products and regimes. They are strong
advocates of good science and take the necessary time to complete
compound studies, formulations, and appropriate marketing analyses.
The launch date for TFC-1067 was established early in the program
and R+F have not altered that date. We have been informed last week
that they are still on track for the scheduled launch. Our
established manufacturing will ensure that enough product will be
produced to meet the demand for TFC-1067 without delays.
Q: Is the antiviral program on hold?
The antiviral program is not formally on hold, but resources
have been temporarily shifted to the anti-aging program as the team
in France works on testing various
compounds in the library. We have had good results that require
further investigation and we felt that shifting the strategy to
this program made sense for now. We are actively seeking
partnerships while we confirm results. We have new anti-aging
compounds which we believe are even more commercially promising
both in ease of manufacturing as well as effectiveness. Testing of
these new compounds became a priority to secure the patents.
Q: Has COVID-19 had an impact on deal progress?
Yes. COVID-19 has not impacted our ability to work internally
but has impacted the ability of our team to travel. Much of our
business in China traditionally
relies on face-to-face meetings that simply cannot take place so we
have adapted. Fortunately, we do have consultants in China who are able to progress our business
development. We will resume travel as soon as possible but will not
delay business development in the meantime.
Q: What is happening with the diabetic therapy for
animals?
Our partner completed extensive due diligence that went beyond
the initially set timeline. They have reported to us they are at
the very final stages of that process and will be moving to the
next level of engagement. We expect an update on this project soon,
however, we caution that due to holidays, we cannot be certain that
news will be released prior to year-end.
Q: Is Sirona going to improve investor
communications?
We are actively working to improve communications. This FAQ
sheet is part of that process. You will see more changes over the
next few months as we work to keep our shareholders informed of our
latest developments. This includes a stronger social media presence
and quarterly shareholder updates.
Best Regards,
Dr. Howard Verrico
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery
company with a proprietary platform technology. Sirona specializes
in stabilizing carbohydrate molecules with the goal of improving
efficacy and safety. New compounds are patented for maximum revenue
potential.
Sirona's compounds are licensed to leading companies around the
world in return for licensing fees, milestone fees and ongoing
royalty payments. Sirona's laboratory, TFChem, is located in
France and is the recipient of
multiple French national scientific awards and European Union and
French government grants. For more information, please visit
www.sironabiochem.com.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this
release.
Sirona Biochem cautions you that statements included in this
press release that are not a description of historical facts may be
forward-looking statements. Forward-looking statements are only
predictions based upon current expectations and involve known and
unknown risks and uncertainties. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of release of the relevant information, unless
explicitly stated otherwise. Actual results, performance or
achievement could differ materially from those expressed in, or
implied by, Sirona Biochem's forward-looking statements due to the
risks and uncertainties inherent in Sirona Biochem's business
including, without limitation, statements about: the progress and
timing of its clinical trials; difficulties or delays in
development, testing, obtaining regulatory approval, producing and
marketing its products; unexpected adverse side effects or
inadequate therapeutic efficacy of its products that could delay or
prevent product development or commercialization; the scope and
validity of patent protection for its products; competition from
other pharmaceutical or biotechnology companies; and its ability to
obtain additional financing to support its operations. Sirona
Biochem does not assume any obligation to update any
forward-looking statements except as required by law.
SOURCE Sirona Biochem Corp.